Penumbra Coil 400 400PAC40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948021334), received between Nov 14, 2022 and Sep 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID CAVERNOUS FISTULA (CCF) USING PAC400 COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PAC400 COILS INTO THE TARGET VESSEL USING THE PX SLIM. WHILE ADVANCING ANOTHER PAC400 COIL INTO THE TARGET VESSEL, THE COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE VESSEL. THEREFORE, THE DETACHED PAC400 COIL WAS REMOVED USING A SNARE DEVICE AND A GUIDE CATHETER. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL PAC400 COILS AND TWO PX SLIMS. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED THE PXSLIM 45 DEGREE TO A STRAIGHT IN ORDER TO REACH A DIFFERENT PART OF THE CCF. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043522 ↗
• MalfunctionDec 9, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A PAC400 COIL AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL IN THE TARGET LOCATION USING THE RUBY COIL DETACHMENT HANDLE (HANDLE). THE PAC400 WAS THEN ADVANCED THROUGH THE PX SLIM UP THE RIGHT VERTEBRAL AND DOWN THE LEFT VERTEBRAL ARTERY TO THE TARGET LOCATION AND THE PHYSICIAN NOTICED THAT THE PAC400 HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE PAC400 WAS NOT SECURE IN THE TARGET VESSEL. A SNARE DEVICE WAS USED TO RETRIEVE THE PAC400. THE PROCEDURE WAS COMPLETED AT THIS POINT AND THE PHYSICIAN DECIDED NO ADDITIONAL COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298354 ↗
• MalfunctionNov 14, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PAC400S, POD COILS, A NON-PENUMBRA VASCULAR PLUG, AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS AND A NON-PENUMBRA VASCULAR PLUG IN THE TARGET LOCATION. NEXT, WHILE ADVANCING A PAC400 COIL THROUGH THE PX SLIM, THE PX SLIM WAS KINKED AND, CONSEQUENTLY, THE PAC400 COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE WAS USED TO REMOVE THE DETACHED PAC400 COIL. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794510 ↗